Sanofi-a Ventis Deutschland Gmbh

Pelikan Technologies, Inc.

Jon Hewitt Leonard

Dominique M Freeman

Don Alden

Barry Dean Briggs

Dirk Boecker

Ray Freeman

George Gogue

Dirk Boecher

A sampling module includes a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel. A cover sheet is disposed over the lancet and a lancet channel that captures the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.

Tissue penetration device

An agent injection device is provided that is capable of injecting an agent to a known predetermined tissue depth. An injection member has an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time. A controllable driver is coupled to the elongate injection shaft and is configured to drive the injection member into target tissue. A velocity control system is in communication with the controllable driver and is configured to control the velocity of the elongate injection shaft.

A moving coil tissue penetration device includes a magnetic source that produces a magnetic field in a magnetically active region. A cylindrical coil is secured to a translation substrate and disposed at least partially within the magnetically active region. A sharpened member is configured to penetrate tissue and mechanically coupled to the translation substrate.

A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue and a shaft portion. The tissue penetration element is disposed in proximity to the tissue of the patient. The tissue penetration element is driven distally towards the tissue of the patient. Contact is made between the tip and the tissue of the patient. The tip is advanced into the tissue during a penetration stroke to a position of maximum inward displacement. The tissue penetration element is allowed to settle upon reaching the point of maximum inward penetration for at least about 1 millisecond with no driving force imposed on the tissue penetration element. The tissue penetration element is displaced proximally over a withdrawal stroke and the tip is removed from the tissue.

A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue and a shaft portion. The tissue penetration element is disposed in proximity to the tissue of the patient. The tissue penetration element is driven distally towards the tissue of the patient. Contact is made between the tip and the tissue of the patient. The tip is advanced into the tissue during a penetration stroke to a position of maximum inward displacement. The tissue penetration element is displaced proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke. The tip is removed from the tissue.

A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue. The tissue penetration element is disposed in proximity to the tissue of the patient. A lancing cycle is initiated. The lancing cycle advances the tip into the tissue during a penetration stroke and displaces the tissue penetration element proximally over a withdrawal stroke. Tissue data is acquired based on an interaction between the tissue penetration element and the tissue during at least a portion of the lancing cycle.

A system is provided that controls movement of a lancet. One or more processors execute program instructions and receive a data set. The program instructions are executed to cause the processor to, cause force to be applied to the lancet to thereby cause the lancet to move in a first direction toward a target, monitor position and speed of the lancet as the lancet moves in the first direction, adjust the application of force to the lancet as the lancet moves in the first direction to achieve a desired speed of the lancet, and adjust the application of force to the lancet when the lancet contacts the target so that the lancet penetrates the target within a desired range of speed.

A lancet belt has a first belt tape with a longitudinal axis and an adhesion material disposed on an adhesion side of the tape. A second belt tape has a longitudinal axis disposed on the adhesion side of the first tape with the longitudinal axes of the first belt tape and the second belt tape being substantially parallel. A plurality of lancets are disposed between the first belt tape and the second belt tape. Longitudinal axes of the lancets are substantially orthogonal to the longitudinal axes of the first and second belt tapes.

A method is provided for controlling a lancet velocity profile. A velocity of a moving lancet is measured at a known position. The measured velocity of the lancet is compared with an appropriate velocity for the lancet at the known position. A force is applied to the lancet to adjust the velocity of the lancet.

A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver of includes a drive force generator for advancing the lancet along a path into the tissue site, and a sensor configured to detect lancet position along said path during the lancing cycle.

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Sunnyvale, CA, United States of America

Jon Hewitt Leonard